Method for promoting sleep

ABSTRACT

Supplemental compositions, and methods for administering same to a user, are provided for promoting a restful night&#39;s sleep by speedily inducing a person to fall asleep and to maintain sleep, as well as alleviating minor aches and pains so as to further improve the quality of a person sleep. The supplemental composition may include at least an extract of Valerian Root, an extract of Willow Bark and Melatonin or a derivative thereof. The supplemental composition may be provided for consumption at least one time daily, e.g., prior to sleep.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/486,866 (U.S. Pat. No. 7,476,405) filed Jul. 14, 2006, which in turnis related to and claims benefit of priority to Applicant's U.S.Provisional Patent Application Ser. No. 60/776,325 entitled“Compositions and Methods for Increasing Bioavailability of Compositionsfor Performance Improvement”, filed Feb. 23, 2006, the disclosure ofwhich is hereby fully incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to a composition to aid in the inductionand maintenance of sleep in a user, e.g., human.

BACKGROUND OF THE INVENTION

Sleep typically occupies about one-third of a person's life and affectsa person's mental and physical well-being. It additionally affects mood,behavior and physiology. Sleep and the control of sleep is a complexprocess involving multiple chemicals and brain structures. It is adynamic process involving distinct physiological changes and involvesboth positive and negative signaling. The regulation of sleep in humansis governed by three processes—each influenced by hormonal andenvironmental factors: a daily sleep-wake cycle influenced by acircadian rhythm (24 hour cycle) tied to light-dark cycles controlled bya cluster of about 10,000 neurons located in the hypothalamus behind theeyes, called the suprachiasmatic nuclei (Hastings M H. Central clocking.Trends Neurosci. 1997 October; 20(10):459-64.); a separable oscillatingsleep homeostatic process influenced by prior sleep (Dijk D J, Lockley SW. Integration of human sleep-wake regulation and circadian rhythmicity.J Appl Physiol. 2002 February; 92(2):852-62.); and an ultradian rhythmwhich occurs within the 24 hour circadian cycle.

The need for sleep is a biological drive similar to thirst or hunger.Interestingly though, the function of sleep is largely unknown, howeversome evidence indicates that sleep is required for learning (StickgoldR, James L, Hobson J A. Visual discrimination learning requires sleepafter training. Nat Neurosci. 2000 December; 3(12):1237-8.; Gais S,Plihal W, Wagner U, Born J. Early sleep triggers memory for early visualdiscrimination skills. Nat Neurosci. 2000 December; 3(12):1335-9.).Additionally, sleep deprivation studies in rats have shown that whenrats are not allowed to sleep, the end-result is death apparentlyrelated to immune system failure (Everson C A. Sustained sleepdeprivation impairs host defense. Am J Physiol. 1993 November; 265(5 Pt2):R1148-54.). In humans, similarly, mild sleep deprivation also resultsin indications of impaired immune system function (Irwin M, McClintickJ, Costlow C, Fortner M, White J, Gillin J C. Partial night sleepdeprivation reduces natural killer and cellular immune responses inhumans. FASEB J. 1996 April; 10(5):643-53.). Although specific sleeprequirements vary from individual to individual, sleeping less than sixhours per day has been shown to increase the risk of glucose intoleranceand diabetes (Gottlieb D J, Punjabi N M, Newman A B, Resnick H E,Redline S, Baldwin C M, Nieto F J. Association of sleep time withdiabetes mellitus and impaired glucose tolerance. Arch Intern Med. 2005Apr. 25; 165(8):863-7.). Insomnia has been estimated to affect 40% ofNorth Americans per year (Stoller M K. Economic effects of insomnia.Clin Ther. 1994 September-October; 16(5):873-97). A study by the U.S.National Sleep Foundation and the Gallup Organization involving 1,000randomly selected Americans revealed that insomnia negatively impactsactivities during waking function and effects quality of life (Roth T,Ancoli-Israel S. Daytime consequences and correlates of insomnia in theUnited States: results of the 1991 National Sleep Foundation Survey. II.Sleep. 1999 May 1; 22 Suppl 2: S354-8.). Another study involving 261insomnia sufferers and 101 individuals with no sleep complaints revealedthat insomnia significantly impairs quality of life (Zammit G K, WeinerJ, Damato N, Sillup G P, McMillan C A. Quality of life in people withinsomnia. Sleep. 1999 May 1; 22 Suppl 2:S379-85.).

The neurotransmitter Gamma Aminobutyric Acid (GABA) is a primaryinhibitory neurotransmitter. One of its effects is to induce sleep. TheGABA-receptors are associated with chloride ion channels—signalingthrough the GABA-receptor changes the electrochemical gradient of theneuron, leading to activity inhibition (Olsen R W, Tobin A J. Molecularbiology of GABAA receptors. FASEB J. 1990 March; 4(5):1469-80).Benzodiazepines are thought to act via interaction with the GABAreceptor; enhancing the inhibitory effects of GABA. As such,Benzodiazepines are a widely used class of drugs primarily used astranquilizers, muscle-relaxants, hypnotics or sedatives (Valenstein M,Taylor K K, Austin K, Kales H C, McCarthy J F, Blow F C. Benzodiazepineuse among depressed patients treated in mental health settings. Am JPsychiatry. 2004 April; 161(4):654-61.). Additionally, Adenosine, aneuromodulator, may induce sleep by extracellular accumulation inspecific brain regions such as the basal forebrain during prolongedwakefulness (Strecker R E, Morairty S, Thakkar M M, Porkka-Heiskanen T,Basheer R, Dauphin L J, Rainnie D G, Portas C M, Greene R W, McCarley RW. Adenosinergic modulation of basal forebrain and preoptic/anteriorhypothalamic neuronal activity in the control of behavioral state. BehavBrain Res. 2000 November; 115(2):183-204.; Zeitzer J M,Morales-Villagran A, Maidment N T, Behnke E J, Ackerson L C,Lopez-Rodriguez F, Fried I, Engel J Jr, Wilson C L. Extracellularadenosine in the human brain during sleep and sleep deprivation: an invivo microdialysis study. Sleep. 2006 Apr. 1; 29(4):455-61.). Actions onboth the GABA-benzodiazepine receptor complex (Mendelson W B.Sleep-inducing effects of adenosine microinjections into the medialpreoptic area are blocked by flumazenil. Brain Res. 2000 Jan. 10;852(2):479-81.) and/or the adenosine A1 receptor (Thakkar M M, WinstonS, McCarley R W. A1 receptor and adenosinergic homeostatic regulation ofsleep-wakefulness: effects of antisense to the A1 receptor in thecholinergic basal forebrain. J Neurosci. 2003 May 15; 23(10):4278-87.)can lead to the induction and maintenance of sleep. The stimulatoryeffects of caffeine are thought to be due to antagonism of adenosine A1receptors (Sawynok J. Pharmacological rationale for the clinical use ofcaffeine. Drugs. 1995 January; 49(1):37-50.), wherein an aroused stateis observed.

Another chemical associated with sleep is Melatonin. It is a hormoneproduced by the pineal gland from the amino acid tryptophan. Productionis rhythmic in keeping with an intrinsic cycle of approximately 24-hoursin duration, wherein levels are low during the day and increasingtowards the nighttime (Wyatt J K, Ritz-De Cecco A, Czeisler C A, Dijk DJ. Circadian temperature and melatonin rhythms, sleep, andneurobehavioral function in humans living on a 20-h day. Am J Physiol.1999 October; 277(4 Pt 2):R1152-63). Melatonin appears to have twodistinct effects on the circadian clock: neuronal inhibition andphase-shifting of the sleep cycle (Liu C, Weaver D R, Jin X, Shearman LP, Pieschl R L, Gribkoff V K, Reppert S M. Molecular dissection of twodistinct actions of melatonin on the suprachiasmatic circadian clock.Neuron. 1997 July; 19(1):91-102.). Oral administration of supplementalmelatonin during the day induces sleepiness and improves night sleep(Dollins A B, Zhdanova I V, Wurtman R J, Lynch H J, Deng M H. Effect ofinducing nocturnal serum melatonin concentrations in daytime on sleep,mood, body temperature, and performance. Proc Natl Acad Sci USA. 1994Mar. 1; 91(5):1824-8.). Two types of melatonin G-protein coupledreceptors have been classified in mammals and termed MT1 and MT2(Dubocovich M L, Markowska M. Functional MT1 and MT2 melatonin receptorsin mammals. Endocrine. 2005 July; 27(2):101-10.).

Serotonin (5-hydroxytryptamine, 5HT), like melatonin, also displays adiurnal pattern; however, it functions in an opposing rhythm withdaytime levels being higher than nighttime levels Portas C M, BjorvatnB, Fagerland S, Gronli J, Mundal V, Sorensen E, Ursin R. On-linedetection of extracellular levels of serotonin in dorsal raphe nucleusand frontal cortex over the sleep/wake cycle in the freely moving rat.Neuroscience. 1998 April; 83(3):807-1.). Three basic serotonin receptortypes have been identified: 5HT-1, 5HT-2 and 5HT-3. Several subtypes of5HT-1 have also been identified. The exact response of cells toserotonin depends on the receptor types expressed (Andrade R. ofmembrane excitability in the central nervous system by serotoninreceptor subtypes. Ann N Y Acad Sci. 1998 Dec. 15; 861:190-203.)however, Serotonin has been shown to inhibit GABA receptors (Feng J, CaiX, Zhao J, Yan Z. Serotonin receptors modulate GABA(A) receptor channelsthrough activation of anchored protein kinase C in prefrontal corticalneurons. J Neurosci. 2001 Sep. 1; 21(17):6502-11.), likely contributingto the opposing actions of serotonin and GABA and play a role in sleep.

SUMMARY OF THE INVENTION

The present invention according to one embodiment thereof, provides fora composition directed towards the induction of sleep. Morespecifically, the invention is directed towards a sleep-promoting andpain-relief composition. Advantageously, the sleep-promoting andpain-relief composition of the present invention may additionallyprovide for maintenance of sleep, thereby promoting a good quality,restful sleep as well as alleviating minor aches and pains, thus furtherimproving the quality of the person's sleep. The composition of thepresent invention comprises an extract of Valerian Root, an extract ofWillow Bark and Melatonin or a derivative thereof. For example, thepresent invention may be effective in promoting a restful night's sleepby speedily inducing a person to fall asleep and maintain sleep as wellas alleviating minor aches and pains further improving the quality of anindividual's, e.g. a human or animal, sleep. Furthermore, the presentinvention advantageously provides a method for the maintenance of sleepthereby promoting a good quality, restful sleep as well as alleviatingminor aches and pains, thus further improving the quality of anindividual's, e.g. human or animal, sleep by administering to a human ora animal a composition comprising an extract of Valerian Root, anextract of Willow Bark and Melatonin or a derivative thereof.

According to an embodiment, the present invention may provide acomposition comprising an extract of Valerian Root, an extract of WillowBark and Melatonin or a derivative thereof. Additionally, thecomposition may include one or more of an extract of Hops cone, Lavenderflower powder, an extract of Passionflower, Skullcap powder, an extractof Coenzyme Q10, a leaf of extract Lemon Balm. The composition mayinclude a time-release mechanism, e.g., wherein the time-releasemechanism provides 4 hours of active compound release. Also, themelatonin may be incorporated into a tablet coating to promote sleepmore quickly, e.g., to promote instant or immediate sleep. Also, in anembodiment of the present invention, all or a portion of the melatoninmay be fine-milled. Advantageously, the extract of Valerian Root, theextract of Willow Bark and the Melatonin or a derivative thereof, areprovided in amounts effective to at least one of promote sleep andrelieve pain.

DETAILED DESCRIPTION OF THE INVENTION

The present invention according to an embodiment thereof isadvantageously directed towards a sleep-promoting and pain-reliefcomposition which, for example, may induce sleep and promote themaintenance of sleep leading to a restful night's sleep, as well asalleviate minor aches and pains, further improving the quality of aperson's sleep. Compounds employed in various embodiments of the presentinvention have been shown to be active at receptor sites in the centralnervous system that relate to the induction and maintenance of sleep.Moreover, the composition of the present invention also containscompounds shown to alleviate minor aches and pains.

In an embodiment, the present invention may include the use ofcombinations, wherein the combination includes, without being limitedto, one or more of the following: Melatonin, Coenzyme Q10, Lemon Balmleaf extract, Hops cone extract, Lavender flower extract, Passionflowerextract, Skullcap, deodorized Valerian root and Willow bark extract. Thesupplement may be consumed in any form, e.g., a capsule, a tablet, acaplet, a liquid beverage, a powder beverage mix, or as a dietary gel.The preferred dosage form of the present embodiment is a timed releasecaplet.

As set forth above, the dosage form of the diet supplement, inaccordance with the example embodiment set forth below, may be providedin accordance with customary processing techniques for herbal and/ordietary supplements, wherein the active ingredients are suitablyprocessed into a desired form. In accordance with an embodiment of thepresent invention, one or more ingredients of the diet supplement areprocessed so as to form fine-milled particles. For instance, in anembodiment, one or more ingredients of the supplemental dietarycomposition is processed by a large-scale dry milling technique thatproduces fine particles, preferably known as fine-milled particles. Theuse of dry milling techniques, in combination with excipients andpolymers, to form fine-milled particles has been shown to improve flowand dispersability, stability, resistance to moisture, bioavailability,and dissolution/release properties. Formulations may benefit bycontaining fine-milled particles because providing one or moreingredients in fine-milled particle sizes may optimize one or more ofthe flow and dispersability, stability, resistance to moisture,bioavailability, and dissolution/release properties of the one or moreingredients in a diet supplement. In vitro tests designed to simulatethe environment of a stomach were performed to test the dissolution rateof fine-milled particle tablets relative to tablets having particlesthat are not fine-milled. These test showed that in tablets producedfrom fine-milled particles the time to 100% dissolution wasapproximately 15 minutes. In the case of non-fine-milled particlecompositions, only 90% dissolution was observed after 120 minutes. In apreferred embodiment, the supplemental composition contains fine-milledparticles having an average size between about 2 nm and about 50 nm.

U.S. Provisional Patent Application 60/776,325 discloses a method forimproving the absorption, palatability, taste, texture, andbioavailability of compounds by increasing the solubility of compoundsin proprietary formulations for the purposes of enhancing or improvingmuscle size, growth and/or recovery time and/or weight loss. Theincreased bioavailability of the compound or ingredients is achieved byreducing the particle size via “fine-milling” thereby increasing thesurface area-to-volume ratio of each particle, thus increasing the rateof dissolution. The compositions and methods disclosed promote increasedbioavailability by increasing the total surface area of poorly solubleparticles, thereby increasing the rate of absorption.

As used herein the, term “fine-milled” and/or “fine-milling” refers tothe process of micronization. Micronization is a mechanical process thatinvolves the application of force to a particle, thereby resulting in areduction in the size of the particle. The force, in the case ofmicronization, may be applied in any manner such as, e.g., the collisionof particles at high rates of speed, grinding, or by an air-jetmicronizer. In a preferred embodiment, fine-milled particles areobtained by jet-milling with nitrogen and compressed air.

As used herein, the term “particle size” refers to the diameter of theparticle. The term “average particle size” means that at least 50% ofthe particles in a sample will have the specified particle size.Preferably, at least 80% of the particles in a sample will have thespecified particle size, and more preferably, at least 90% of theparticles in a given sample will have the specified particle size.

The size of a particle can be determined by any of the methods knownwithin the art. Methods for particle size determination which may beemployed are, e.g., sieves, sedimentation, electrozone sensing (Coultercounter), microscopy, and/or Low Angle Laser Light Scattering. Thepreferred methods for the particle size determination of the presentinvention are the methods which are most commonly used in thepharmaceutical industry, such as laser diffraction, e.g., via lightscattering Coulter Delsa 440SX.

The fine-milling process may be employed in the processing of one ormore of the ingredients of the present invention in the dosage forms oftablets (e.g., immediate-release film coated, modified-release andfast-dissolving), capsules (e.g., immediate-release andmodified-release), liquid dispersions, powders, drink mixes, etc.

Furthermore, the dosage form of the nutritional supplement in accordancewith the aforementioned embodiment or further embodiments as interpretedby one of skill in the art related to the present invention may beprovided in accordance with customary processing techniques for herbaland/or dietary and/or nutritional supplements in any of the formsmentioned above.

Melatonin

Melatonin is a hormone produced by the pineal gland from tryptophan andis involved in sleep regulation (Reiter R J. melatonin: cell biology ofits synthesis and of its physiological interactions. Endocr Rev. 1991May; 12(2):151-80.). It is used to treat sleep disorders such asinsomnia and ‘jet lag’ by stimulating the release of specific pituitaryhormones (Ninomiya T, Iwatani N, Tomoda A, Miike T. Effects of exogenousmelatonin on pituitary hormones in humans. Clin Physiol. 2001 May;21(3):292-9.) and adjusting the circadian rhythm to coincide with thelocal day and nighttime.

Melatonin supplementation has been demonstrated to be safe and effectiveat increasing the total amount of sleep time in healthy subjects(Matsumoto M. The hypnotic effects of melatonin treatment on diurnalsleep in humans. Psychiatry Clin Neurosci. 1999 April; 53(2):243-5.).Moreover, Melatonin has also been shown to benefit individuals sufferingfrom insomnia (Hughes R J, Sack R L, Lewy A J. The role of melatonin andcircadian phase in age-related sleep-maintenance insomnia: assessment ina clinical trial of melatonin replacement. Sleep. 1998; 21(1):52-68.;Zhdanova I V, Wurtman R J, Regan M M, Taylor J A, Shi J P, Leclair O U.Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab.2001 October; 86(10):4727-30.; Brzezinski A, Vangel M G, Wurtman R J,Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenousmelatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 February;9(1):41-50.) by way of the induction of sleep. The most common effect ofmelatonin on sleep is a reduction in sleep latency, the time taken tofall asleep (Zhdanova I V, Wurtman R J, Lynch H J, Ives J R, Dollins AB, Morabito C, Matheson J K, Schomer D L. Sleep-inducing effects of lowdoses of melatonin ingested in the evening. Clin Pharmacol Ther. 1995May; 57(5):552-8.; Nagtegaal J E, Kerkhof G A, Smits M G, Swart A C, VanDer Meer Y G. Delayed sleep phase syndrome: A placebo-controlledcross-over study on the effects of melatonin administered five hoursbefore the individual dim light melatonin onset. J Sleep Res. 1998 June;7(2):135-43.; Kayumov L, Brown G, Jindal R, Buttoo K, Shapiro C M. Arandomized, double-blind, placebo-controlled crossover study of theeffect of exogenous melatonin on delayed sleep phase syndrome. PsychosomMed. 2001 January-February; 63(1):40-8.; Buscemi N, Vandermeer B, HootonN, Pandya R, Tjosvold L, Hartling L, Baker G, Klassen T P, Vohra S. Theefficacy and safety of exogenous melatonin for primary sleep disorders.A meta-analysis. J Gen Intern Med. 2005 December; 20(12):1151-8.),wherein it reduces the time it takes for an individual to fall asleep.Melatonin may also normalize the circadian rhythm and benefit shiftworkers and individuals with circadian rhythm disorders (Avery D, LenzM, Landis C. Guidelines for prescribing melatonin. Ann Med. 1998February; 30(1):122-30., Kunz D, Mahlberg R, Muller C, Tilmann A, Bes F.Melatonin in patients with reduced REM sleep duration: two randomizedcontrolled trials. J Clin Endocrinol Metab. 2004 January; 89(1):128-34.,Mundey K, Benloucif S, Harsanyi K, Dubocovich M L, Zee P C.Phase-dependent treatment of delayed sleep phase syndrome withmelatonin. Sleep. 2005 Oct. 1; 28(10):1271-8.).

Melatonin may also been shown to be effective in treating seasonaldepression (Lewy A J, Bauer V K, Cutler N L, Sack R L. Melatonintreatment of winter depression: a pilot study. Psychiatry Res. 1998 Jan.16; 77(1):57-61.) and migraines (Peres M F, Zukerman E, da Cunha TanuriF, Moreira F R; Cipolia-Neto J. Melatonin, 3 mg, is effective formigraine prevention. Neurology. 2004 Aug. 24; 63(4):757.). Furthermore,blood pressure as well as stress hormones can be reduced by daily oraladministration of melatonin in healthy men (Arangino S, Cagnacci A,Angiolucci M, Vacca A M, Longu G, Volpe A, Melis G B. Effects ofmelatonin on vascular reactivity, catecholamine levels, and bloodpressure in healthy men. Am J Cardiol. 1999 May 1; 83(9):1417-9.).

One aspect of the present invention includes the use of Melatonin forthe regulation of sleep. U.S. Pat. Nos. 6,703,412, 5,716,978, and5,641,801 disclose methods of treating sleeplessness, sleep latencyperiod, circadian rhythm disorders involving Melatonin.

For example, U.S. Pat. No. 6,703,412, entitled “Method of TreatingSleeplessness with Melatonin on an Acute Basis” purports to describe amethod of treating sleeplessness in a human comprising theadministration of an effective amount of not greater than 10 mg ofmelatonin or a pharmaceutically acceptable salt thereof. The methodfurther comprises the administration of melatonin after a person hastried and failed to go to sleep, or has awakened from sleep and isunable to return to sleep. The method may be employed up to one hourfrom the person's desired waking time.

U.S. Pat. No. 5,716,978, entitled “Methods of Treating Circadian RhythmDisorders” describes a method in which infants and blind humans employthe administration of Melatonin to produce a phase-shifting effect andreinstate a proper circadian rhythm. The method involves theadministration of Melatonin from about 6 hours to about 19 hours priorto when a normal sleep phase should begin. The administration ofMelatonin is to be less than 1 mg and at a time prior to a person'sendogenous Melatonin onset time.

U.S. Pat. No. 5,641,801 entitled “Method of Reducing the Period beforethe Onset of Sleep” purports to describe a method of inducing sleep inan individual via the administration of a single dose of Melatonincomprising less than 1 mg to raise the peak plasma Melatonin levels towithin physiological nocturnal levels of normal untreated individuals.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeMelatonin. A serving of the supplemental composition may include fromabout 0.001 g to about 0.01 g of Melatonin. The preferred dosage of aserving of the supplemental composition comprises about 0.0040 g ofMelatonin.

Furthermore, in an embodiment of the present invention, which is setforth in greater detail in Example 1 below, the supplemental compositionmay include fine-milled Melatonin. A serving of the supplementalcomposition may include from about 0.0001 g to about 0.01 g offine-milled Melatonin. The preferred dosage of a serving of thesupplemental composition comprises about 0.0010 g of fine-milledMelatonin.

CoQ10

Coenzyme Q10 (CoQ10, ubiquinone) is found in the mitochondria of allcells and is involved in energy production. It is found at its highestconcentrations in the heart, liver, kidney and pancreas. CoQ10 is apotent antioxidant in human blood (Weber C, Sejersgard Jakobsen T,Mortensen S A, Paulsen G, Holmer G. Antioxidative effect of dietarycoenzyme Q10 in human blood plasma. Int J Vitam Nutr Res. 1994;64(4):311-5.) where it also acts to preserve vitamin E, another majorantioxidant (Thomas S R, Neuzil J, Stocker R. Inhibition of LDLoxidation by ubiquinol-10. A protective mechanism for coenzyme Q inatherogenesis? Mol Aspects Med. 1997; 18 Suppl:S85-103).

Due to its high concentrations in the heart, CoQ10 is believed tobenefit and strengthen the heart. Many heart-related diseases arethought to result from defective myocardial energy production andnumerous studies have suggested that supplementation with CoQ10 isbeneficial (Mortensen S A. Perspectives on therapy of cardiovasculardiseases with coenzyme Q10 (ubiquinone). Clin Investig. 1993; 71(8Suppl):S116-23.). A meta-analysis of eight clinical trials supports theefficacy of CoQ10 for the treatment of congestive heart failure (Soja AM, Mortensen S A. Treatment of congestive heart failure with coenzymeQ10 illuminated by meta-analyses of clinical trials. Mol Aspects Med.1997; 18 Suppl:S159-68.). Another study has shown that individualssuffering from angina were able to exercise for longer periods whenreceiving CoQ10 (Kamikawa T, Kobayashi A, Yamashita T, Hayashi H,Yamazaki N. Effects of coenzyme Q10 on exercise tolerance in chronicstable angina pectoris. Am J Cardiol. 1985 Aug. 1; 56(4):247-51.) ascompared to untreated groups. Moreover, myocardial function was improvedby CoQ10 in patients with disease conditions known to involve energyproduction deficits (Folkers K, Wolaniuk J, Simonsen R, Morishita M,Vadhanavikit S. Biochemical rationale and the cardiac response ofpatients with muscle disease to therapy with coenzyme Q10. Proc NatlAcad Sci USA. 1985 July; 82(13):4513-6.) wherein these patients alsoreported a ‘subjective’ improved sense of well-being. CoQ10 supplementedwith iron and vitamin B6 has also appeared to prevent the progression ofAlzheimer's disease, a neurological disease often associated withimpaired mitochondrial function (Imagawa M, Naruse S, Tsuji S, FujiokaA, Yamaguchi H. Coenzyme Q10, iron, and vitamin B6 ingenetically-confirmed Alzheimer's disease. Lancet. 1992 Sep. 12;340(8820):671.). Moreover, in another neurological disorder, CoQ10 in aphase II clinical trial was reported to slow the progression ofParkinson's disease (Shults C W, Oakes D, Kieburtz K, Beal M F, Haas R,Plumb S, Juncos J L, Nutt J, Shoulson I, Carter J, Kompoliti K,Perlmutter J S, Reich S, Stern M, Watts R L, Kurlan R, Molho E, HarrisonM, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in earlyParkinson disease: evidence of slowing of the functional decline. ArchNeurol. 2002 October; 59(10):1541-50.) which often results in disturbedsleep and has been shown to involve impaired mitochondrial function andlow levels of CoQ10 (Shults C W, Haas R H, Passov D, Beal M F. CoenzymeQ10 levels correlate with the activities of complexes I and II/III inmitochondria from parkinsonian and nonparkinsonian subjects. Ann Neurol.1997 August; 42(2):261-4.).

Furthermore, CoQ10 has been successfully used to treat high bloodpressure, eliminating the need for medication in many cases (LangsjoenP, Langsjoen P, Willis R, Folkers K. Treatment of essential hypertensionwith coenzyme Q10. Mol Aspects Med. 1994; 15 Suppl:S265-72.). Migraineshave also been successfully and safely treated with CoQ10 (Sandor P S,Di Clemente L, Coppola G, Saenger U, Fumal A, Magis D, Seidel L, AgostiR M, Schoenen J. Efficacy of coenzyme Q10 in migraine prophylaxis: arandomized controlled trial. Neurology. 2005 Feb. 22; 64(4):713-5.) mostlikely due its effects on blood pressure.

In a Japanese study, CoQ10 was shown to provide relieve from snoring inabout half of the subjects, displaying a decrease in the sound level oftheir snoring (Takasaki Y, Yoshida H, Kaneko Y, Kaneda R, Kurosaki S,Yamadera Y., An Analysis of Effectiveness of Activated Co-enzyme Q10 onSubjects by Using Acoustic Technology. Biopharma Ltd. Tokyo Japan).Specifically, about 44% of subjects displayed a decrease in the soundlevel of their snoring during the REM stage of sleep, about 40% ofsubjects showed a decrease in the sound level of their snoring duringnon-REM sleep stages I/II, and about 33% of subjects showed a decreasein the sound level of their snoring during non-REM sleep stages III/IV.Furthermore, subjects reported in questionnaires that their feeling ofrestfulness was improved upon waking.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeCoEnzyme Q10. A serving of the supplemental composition may include fromabout 0.0005 g to about 0.1000 g of CoEnzyme Q10. The preferred dosageof a serving of the supplemental composition comprises about 0.0010 g ofCoEnzyme Q10.

Lemon Balm Leaf Extract

The plant Melissa officinalis, commonly known as Lemon balm is a memberof the mint family and is often referred to as “the calming herb”. Lemonbalm extract has proven antioxidant activity which likely contributes toits beneficial effects (Hohmann J, Zupko I, Redei D, Csanyi M, Falkay G,Mathe I, Janicsak G. Protective effects of the aerial parts of Salviaofficinalis, Melissa Officinalis and Lavandula angustifolia and theirconstituents against enzyme-dependent and enzyme-independent lipidperoxidation. Planta Med. 1999 August; 65(6):576-8.). However, in thecentral nervous system, it possesses acetylcholine receptor activity(Wake G, Court J, Pickering A, Lewis R, Wilkins R, Perry E.acetylcholine receptor activity in European medicinal plantstraditionally used to improve failing memory. J Ethnopharmacol. 2000February; 69(2):105-14.), therefore suggesting that it may have anotherpossible mechanism of action relating to cell-signaling.

Randomized, placebo-controlled, double-blind clinical studiesinvestigating the acute effects of Lemon balm extract on cognition andmood have demonstrated a calming effect (Kennedy D O, Scholey A B,Tildesley N T, Perry E K, Wesnes K A. Modulation of mood and cognitiveperformance following acute administration of Melissa officinalis (lemonbalm). Pharmacol Biochem Behav. 2002 July; 72(4):953-64.) in addition tothe effect of improved mood (Kennedy D O, Wake G, Savelev S, Tildesley NT, Perry E K, Wesnes K A, Scholey A B. Modulation of mood and cognitiveperformance following acute administration of single doses of Melissaofficinalis (Lemon balm) with human CNS nicotinic and muscarinicreceptor-binding properties. Neuropsychopharmacology. 2003 October;28(10):1871-81.). Lemon balm extract has also shown potential inreducing the negative mood effects of stress in clinical trials (KennedyD O, Little W, Scholey A B. Attenuation of laboratory-induced stress inhumans after acute administration of Melissa officinalis (Lemon Balm).Psychosom Med. 2004 July-August; 66(4):607-13.).

Moreover, the cognitive function of Alzheimer's patients has been shownto be improved by the use Lemon balm extract (Akhondzadeh S, NoroozianM, Mohammadi M, Ohadinia S, Jamshidi A H, Khani M. Melissa officinalisextract in the treatment of patients with mild to moderate Alzheimer'sdisease: a double blind, randomised, placebo controlled trial. J NeurolNeurosurg Psychiatry. 2003 July; 74(7):863-6.). In this study, thetreatment group also displayed less agitation than the placebo group,suggesting an improvement in mood. Furthermore, clinical trials havedemonstrated that Lemon balm can be effective at reducing stress andanxiety when used in combination with Valeriana (Kennedy D O, Little W,Haskell C F, Scholey A B. Anxiolytic effects of a combination of Melissaofficinalis and Valeriana officinalis during laboratory induced stress.Phytother Res. 2006 February; 20(2):96-102.). Another study has shownthat when presented in a lozenge also containing Lavender oil and hops,Lemon balm can alter brain-waves related to working memory, leading tothe induction of a state of relaxation and an improved ability to copewith emotional and physiological stress (Dimpfel W, Pischel I, LehnfeldR. Effects of lozenge containing lavender oil, extracts from hops, lemonbalm and oat on electrical brain activity of volunteers. Eur J Med Res.2004 Sep. 29; 9(9):423-31.).

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeLemon Balm leaf extract. A serving of the supplemental composition mayinclude from about 0.0010 g to about 0.1000 g of Lemon Balm leafextract. The preferred dosage of a serving of the supplementalcomposition comprises about 0.0800 g of Lemon Balm leaf extract.

Hops Cone Extract (Humulus lupulus)

The hop plant (Humulus lupulus) is a flowering vine used traditionallyas a sedative to assist with anxiety reduction and sleep difficulties.In mice, hops extract displays sleep-enhancing and antidepressantactivities (Zanoli P, Rivasi M, Zavatti M, Brusiani F, Baraldi M. Newinsight in the neuropharmacological activity of Humulus lupulus L.JEthnopharmacol. 2005 Oct. 31; 102(1):102-6.).

In vitro tests have shown that hops contain compounds with antioxidantand chemoprotective activity as well as compounds that can inducedetoxification enzymes (Dietz B M, Kang Y H, Liu G, Eggler A L, Yao P,Chadwick L R, Pauli G F, Farnsworth N R, Mesecar A D, van Breemen R B,Bolton J L. Xanthohumol isolated from Humulus lupulus Inhibitsmenadione-induced DNA damage through induction of quinone reductase.Chem Res Toxicol. 2005 August; 18(8):1296-305.).

A combination of valerian and hops has been shown to interact withadenosine receptors (Muller CE, Schumacher B, Brattstrom A, Abourashed EA, Koetter U. Interactions of valerian extracts and a fixed valerian-hopextract combination with adenosine receptors. Life Sci. 2002 Sep. 6;71(16):1939-49.) to aid in the maintenance of sleep. Moreover, bindingof the valerian-hop combination to melatonin and serotonin receptors hasalso been shown (Abourashed E A, Koetter U, Brattstrom A. In vitrobinding experiments with a Valerian, hops and their fixed combinationextract (Ze91019) to selected central nervous system receptors.Phytomedicine. 2004 November; 11(7-8):633-8.). These two receptor typesare also known to be involved in the steep process. Furthermore, hopextract has been shown to modulate the gamma-aminobutyric acid receptor(GABA(A) receptors) and display GABA-like activity (Aoshima H, Takeda K,Okita Y, Hossain S J, Koda H, Kiso Y. Effects of beer and hop onionotropic gamma-aminobutyric acid receptors. J Agric Food Chem. 2006Apr. 5; 54(7):2514-9.) relating to sleep. GABA is an inhibitoryneurotransmitter that can induce relaxation and sleep. Modulation of anyor all of these receptors may mediate the sleep-inducing activity ofhops.

Most of the studies examining the efficacy of hops to aid sleep employhops in combination with other compounds acting on various receptorsknown to be involved in sleep regulation. A combination of valerian andhops has been shown to reduce the time taken to fall asleep and resultsin a more refreshed feeling in the morning in subjects suffering frommild to moderate insomnia (Fussel A, Wolf A, Brattstrom A. Effect of afixed valerian-Hop extract combination (Ze 91019) on sleep polygraphy inpatients with non-organic insomnia: a pilot study. Eur J Med Res. 2000Sep. 18; 5(9):385-90.).

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may include Hopscone extract. A serving of the supplemental composition may include fromabout 0.0010 g to about 0.1000 g of Hops cone extract. The preferreddosage of a serving of the supplemental composition comprises about0.0200 g of Hops cone extract.

Lavender Flower (Lavandula officinalis)

Oil from Lavandula officinalis, commonly known as the Lavender plant isfrequently used in aromatherapy as a mode to induce relaxation. The mildsedative effects of Lavender have been demonstrated in animals andhumans (Lis-Balchin M, Hart S. Studies on the mode of action of theessential oil of lavender (Lavandula angustifolia P. Miller). PhytotherRes. 1999 September; 13(6):540-2.). Further to the sedative effect,Lavender oil has been shown to reduce agitation of patients sufferingfrom dementia (Holmes C, Hopkins V, Hensford C, MacLaughlin V, WilkinsonD, Rosenvinge H. Lavender oil as a treatment for agitated behaviour insevere dementia: a placebo controlled study. Int J Geriatr Psychiatry.2002 April; 17(4):305-8.). Moreover, Lavender has also been shown bebeneficial for treating depression (Akhondzadeh S, Kashani L, Fotouhi A,Jarvandi S, Mobaseri M, Moin M, Khani M, Jamshidi A H, Baghalian K,Taghizadeh M. Comparison of Lavandula angustifolia Mill. tincture andimipramine in the treatment of mild to moderate depression: adouble-blind, randomized trial. Prog Neuropsychopharmacol BiolPsychiatry. 2003 February; 27(1):123-7.). Additionally, thesleep-inducing effects of other compounds may be increased by Lavender(Gyllenhaal C, Merritt S L, Peterson S D, Block K I, Gochenour T.Efficacy and safety of herbal stimulants and sedatives in sleepdisorders. Sleep Med Rev. 2000 June; 4(3):229-251.).

U.S. Pat. No. 5,958,462, entitled “Therapeutic Bath Salts and Method ofUse,” describes a composition comprising magnesium, carbonate and coppercompounds and optionally essential oils including that of Lavender. Thecomposition comprises bath salts purported to be helpful in therelaxation of muscles, elimination or reduction of muscle spasms, andthe overall enhancement of a person's mood when used as an aromatherapy.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeLavender Flower powder. A serving of the supplemental composition mayinclude from about 0.0010 g to about 0.0100 g of Lavender Flower powder.The preferred dosage of a serving of the supplemental compositioncomprises about 0.0050 g of Lavender Flower powder.

Passion Flower Extract

Passion flower has been used traditionally for relaxation and as asleep-aid as well as a treatment for anxiety. The main active componentof Passionflower is thought to by chrysin, one of several flavonoidswhich have been isolated from this plant (Menghini A, Mancini L A. TLCdetermination of flavonoid accumulation in clonal populations ofPassiflora incarnata L. Pharmacol Res Commun. 1988 December; 20 Suppl5:113-6.; Pereira C A, Yariwake J H, Lancas F M, Wauters J N, Tits M,Angenot L. A HPTLC densitometric determination of flavonoids fromPassiflora alata, P. edulis, P. incarnata and P. caerulea and comparisonwith HPLC method. Phytochem Anal. 2004 July-August; 15(4):241-8.). Inmice, chrysin has been shown to act as an agonist of benzodiazepinereceptors and also possess anti-anxiety activity (Wolfman C, Viola H,Paladini A, Dajas F, Medina J H. Possible anxiolytic effects of chrysin,a central benzodiazepine receptor ligand isolated from Passifloracoerulea. Pharmacol Biochem Behav. 1994 January; 47(1):1-4.). Studieshave shown that, in mice, Passionflower extract reduces anxiety andinduces sleep (Soulimani R, Younos C, Jarmouni S, Bousta D, Misslin R,Mortier F. Behavioural effects of Passiflora incarnata L. and its indolealkaloid and flavonoid derivatives and maltol in the mouse. JEthnopharmacol. 1997 June; 57(1):11-20.). Clinical trials in humans havefurther demonstrated that Passionflower is effective in the treatment ofanxiety (Akhondzadeh S, Naghavi H R, Vazirian M, Shayeganpour A, RashidiH, Khani M. Passionflower in the treatment of generalized anxiety: apilot double-blind randomized controlled trial with oxazepam. J ClinPharm Ther. 2001 October; 26(5):363-7.).

One aspect of the present invention includes the use of Passionflowerextract for the reduction of stress and anxiety. U.S. Pat. Nos.6,080,410 and 5,681,578 describe a method and composition, respectively,employing Passionflower extracts for the reduction of stress andanxiety.

U.S. Pat. No. 6,080,410, entitled “Method for Reducing Daily Stress andAnxiety in Adults,” describes a method of employing a novel dietarysupplement which serves a general relaxant comprised of Kava rootextract, and at least one of Passionflower, Chamomile Flower, Hops, andSchizandra Fruit. The method claims to reduce daily stress and anxietyin adults. It is administered in capsule format.

U.S. Pat. No. 5,681,578, entitled “Composition for Relieving StressAnxiety, Grief, And Depression,” describes a composition comprisinggamma Aminobutyric acid, glutamine, glycine, magnesium, passionflower,primal officinalis and vitamin B6. The composition is purported torelieve stress, anxiety, grief and depression.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includePassionflower extract. A serving of the supplemental composition mayinclude from about 0.0010 g to about 0.0100 g of Passionflower extract.The preferred dosage of a serving of the supplemental compositioncomprises about 0.0020 g of Passionflower extract.

Skullcap (Scutellaria lateriflora)

Scutellaria, also known commonly as Skullcap, is a member of the mintfamily and has been used traditionally to treat depression and stress.Studies in mice indicate that Skullcap reduces anxiety (Awad R, ArnasonJ T, Trudeau V, Bergeron C, Budzinski J W, Foster B C, Merali Z.Phytochemical and biological analysis of skullcap (Scutellarialateriflora L.): a medicinal plant with anxiolytic properties.Phytomedicine. 2003 November; 10(8):640-9.). The effects of Skullcap maybe at least partially mediated by antagonism of serotonin receptors(Gafner S, Bergeron C, Batcha L L, Reich J, Arnason J T, Burdette J E,Pezzuto J M, Angerhofer C K. Inhibition of [3H]-LSD binding to 5-HT7receptors by flavonoids from Scutellaria lateriflora. J Nat Prod. 2003April; 66(4):535-7.). A clinical study involving healthy volunteers alsodemonstrated that Skullcap reduces anxiety (Wolfson P, Hoffmann D L. Aninvestigation into the efficacy of Scutellaria lateriflora in healthyvolunteers. Altern Ther Health Med. 2003 March-April; 9(2):74-8.).

U.S. Pat. No. 7,045,158, entitled “Standardized Extracts of ScutellariaLaterifloa,” describes an improved extract of Scutellaria Laterifloa andrelates to a pharmaceutical composition prepared from said extractwherein it is suitable for treating anxiety, insomnia, convulsions,muscle tension and spasms.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeSkullcap powder. A serving of the supplemental composition may includefrom about 0.0001 g to about 0.0100 g of Skullcap powder. The preferreddosage of a serving of the supplemental composition comprises about0.0010 g of Skullcap powder.

Valerian Root (Valeriana officinalis)

Valeriana officinalis, wherein the root, normally called Valerian root,is a perennial herb traditionally used as a sedative and sleep-aid.Compounds from Valerian interact with GABA, melatonin, and/or adenosinesystems through binding to certain melatonin and serotonin receptorsubtypes (Abourashed E A, Koetter U, Brattstrom A. In vitro bindingexperiments with a Valerian, hops and their fixed combination extract(Ze91019) to selected central nervous system receptors. Phytomedicine.2004 November; 11(7-8):633-8.), particularly the 5-HT_(5A) subtype(Dietz B M, Mahady G B, Pauli G F, Farnsworth N R. Valerian extract andvalerenic acid are partial agonists of the 5-HT5a receptor in vitro.Brain Res Mol Brain Res. 2005 Aug. 18; 138(2):191-7.). Interaction withthis receptor is thought to be responsible for the sleep-inducing andmaintenance effect of Valerian root extract.

Valerian root extract has proven to be useful in several clinicaltrials. Subjective self-evaluation of sleep quality improved in avalerian supplemented group as part of a randomized controlled trial(Leathwood P D, Chauffard F, Heck E, Munoz-Box R. Aqueous extract ofvalerian root (Valeriana officinalis L.) improves sleep quality in man.Pharmacol Biochem Behav. 1982 July; 17(1):65-71.), compared to controlgroups. In another clinical trial, the valerian group reported improvedsleep over the placebo group, with 89% of participants reportingimproved sleep (Lindahl O, Lindwall L. Double blind study of a valerianpreparation. Pharmacol Biochem Behav. 1989 April; 32(4):1065-6.). Sleepwas additionally improved in children with various intellectualdeficits, particularly those with hyperactivity (Francis A J, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties inchildren with intellectual deficits: randomised trial. Phytomedicine.2002 May; 9(4):273-9.).

One aspect of the present invention includes the use of Valerian forimproving the quality of sleep and reducing minor aches and pains. U.S.Pat. Nos. 6,869,622 and 6,383,527 describe respective compositions forimproving the quality of sleep and alleviating muscular aches andstrains, particularly with respect to those in the lower back.

For example, U.S. Pat. No. 6,869,622, entitled “Composition forImproving Sleep Quality and Efficiency, And Method of Preparing andUsing the Composition,” describes a pharmaceutically active extract ofthe plant root family of Valerianaceae and its usefulness in improvingsleep quality and efficiency. The patent purports to relate to a methodfor reducing the number of times a patient wakes after sleep onset,comprising administering to the patient a pharmaceutically-activeextract of the root of a plant of the family Valerianaceae, wherein itis processed via an ethanolic and water extraction. Furthermore, asingle dosage is administered between the range of 50 mg and 5000 mgapproximately one-half and two hours prior to bedtime.

U.S. Pat. No. 6,383,527, entitled “Compositions Comprising ValerianExtracts, Isovaleric Acid or Derivatives Thereof with a NSAID,” purportsto describe a combination of valerian extract or isovaleric acid or aderivative in with a non-steroidal anti-inflammatory compound fortreating acute muscular aches, strains and sprains, and in particularlower back pain.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeValerian Root. A serving of the supplemental composition may includefrom about 0.1000 g to about 1.000 g of Valerian Root. The preferreddosage of a serving of the supplemental composition comprises about0.1200 g of Valerian Root.

Willow Bark Extract (Providing Salicin) (Salix alba) 25% Salicin

Willow bark (Salix alba) is a source of salicin, a precursor ofacetylsalicylic acid (aspirin) traditionally used to treat pain, feverand inflammation. In a blind clinical trial, willow bark wasdemonstrated to be effective at relieving back pain (Chrubasik S,Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt C. Treatment oflow back pain exacerbations with willow bark extract: a randomizeddouble-blind study. Am J Med. 2000 July; 109(1):9-14.). After fourweeks, 39% of the high salicin group (n=65) were pain-free, 21% of thelow salicin group (n=67) were pain-free, and only 6% of the placebogroup (n=59) were pain-free. Willow bark extract has also been shown toeffectively reduce arthritis pain (Schmid B, Ludtke R, Selbmann H K,Kotter I, Tschirdewahn B, Schaffner W, Heide L. Efficacy andtolerability of a standardized willow bark extract in patients withosteoarthritis: randomized placebo-controlled, double blind clinicaltrial. Phytother Res. 2001 June; 15(4):344-50.).

The diminishment of bodily pain is an integral part of quality sleep.The inclusion of Willow Back Extract aids in the alleviation of minorbodily pains, leading to an improvement in sleep quality and a reductionin sleep disruption due to discomfort.

One aspect of the present invention includes the use of Willow bark forthe attenuation of minor aches and pains, leading to an improved qualityof sleep. U.S. Pat. Nos. 6,770,263 and 6,312,736 describe compositionsfor the treatment, e.g., alleviation, of aches and pains.

For example, U.S. Pat. No. 6,770,263, entitled “Compositions and Methodsfor the Treatment of Aches and Pains,” purports to describe methods andcompositions useful for treating aches and/or pains. The compositioncomprises an aqueous medium having dispersed or dissolved therein ananalgesic selected from the group consisting of white willow bark,aspirin; ibuprofen, naproxen, and any combination thereof. Thecomposition is then administered in an effective amount across a mucosalmembrane.

U.S. Pat. No. 6,312,736, entitled “Herbal Composition to Relieve Pain,”describes a composition used to relieve pain and other symptomsassociated with migraines and other types of headaches. The compositioncomprises a combination of White Willow bark extract, Kava Kava rootextract, Feverfew extract, Ginger root extract, Guarana extract, andVitamin B6 wherein the composition may be combined with liposomes tocarry the composition in a sublingual dosage for fast pain relief.

In an embodiment of the present invention, which is set forth in greaterdetail in Example 1 below, the supplemental composition may includeWillow bark extract. A serving of the supplemental composition mayinclude from about 0.1000 g to about 1.000 g of Willow bark extract. Thepreferred dosage of a serving of the supplemental composition comprisesabout 0.1500 g Willow bark extract.

The present invention, according to an embodiment thereof, provides amethod which includes the step of consuming a composition, wherein themethod may, for example, alleviate minor aches and pains, speedilyinduce sleep, as well as provide for maintenance of sleep therebypromoting a good quality, restful sleep. In an embodiment of the presentinvention, the method includes the daily consumption, prior to going tosleep with the intent of a full night's sleep, of a sleep-promoting andpain-relief composition that may include at least an extract of ValerianRoot, an extract of Willow Bark and Melatonin or a derivative thereof.Furthermore, the sleep-promoting and pain-relief composition may furthercomprise Coenzyme Q10, Lemon Balm leaf extract, Hops cone extract,Lavender flower extract, Passionflower extract, and Skullcap powder.

The present supplemental composition, or those similarly envisioned byone of skill in the art, may be utilized in methods to alleviate minoraches and pains, speedily induce sleep, as well as provide formaintenance of sleep thereby promoting a good quality, restful sleep ina formulation designed to be consumed on a daily basis prior to going tosleep with the intent of a night's rest.

In an embodiment of the present invention, the composition may include atime-release mechanism, e.g., wherein the time-release mechanismprovides 4 hours of active compound release. Also, in variousembodiments, the melatonin may be incorporated into a tablet coating topromote sleep more quickly, e.g., to promote instant or immediate sleep.

Although the following example illustrates the practice of the presentinvention one of its embodiments the example should not be interpretedas limiting the scope of the invention. Other embodiments of the presentinvention will be apparent to those of skill in the art formconsideration of the specification and example.

EXAMPLE 1

A supplemental composition is provided on a daily basis, prior to goingto sleep with the intent on a full night's rest, the compositionutilizing a dual-release caplet formulation comprising Melatonin (0.0040g), fine-milled Melatonin (0.0010 g), Coenzyme Q10 (0.0010 g), Hops coneextract (0.0200 g), Lavender flower powder (0.0050 g), Passionflowerextract (0.0020 g), Skullcap powder (0.0010 g), Lemon Balm leaf extract(0.0800 g), deodorized Valerian root (0.1200 g) and Willow bark extract(0.1500 g).

Directions: As a supplemental composition, 1 caplet is orallyadministered with an 8 oz. glass of water once daily prior to going tosleep. Preferably, the supplemental composition is consumed with theintent of a full night's sleep.

1. A method for promoting sleep, the method comprising orallyadministering to a human or animal a composition comprising: about0.1200 g of an extract of Valerian Root; about 0.1500 g of an extract ofWillow Bark; about 0.0050 g of Melatonin; about 0.0200 g of an extractof Hops cone; about 0.0050 g of Lavender plant powder; about 0.0020 g ofan extract of Passionflower; about 0.0010 g of Skullcap powder; about0.0010 g of Coenzyme Q10; and about 0.0800 g of an extract of LemonBalm.
 2. The method of claim 1, wherein said Lavender plant is Lavenderflower.
 3. The method of claim 1, wherein promoting sleep includes atleast one of inducing sleep and maintaining sleep.
 4. The method ofclaim 1, wherein the composition is administered to a user once dailyprior to the user going to sleep.
 5. The method of claim 1, wherein thecomposition comprises a time-release mechanism providing about 4 hoursof active compound release.
 6. The method of claim 1, whereincomposition is provided in the form of a coated tablet, and themelatonin is incorporated into the tablet coating.
 7. The method ofclaim 1, wherein at least a portion of the melatonin is fine-milled. 8.A method for promoting sleep, the method comprising orally administeringto a human or animal a composition comprising: an extract of ValerianRoot; an extract of Willow Bark; Melatonin; an extract of Hops cone;Lavender plant powder; an extract of Passionflower; Skullcap powder;Coenzyme Q10; and an extract of Lemon Balm.
 9. The method of claim 8,wherein said Lavender plant is Lavender flower.
 10. The method of claim8, wherein promoting sleep includes at least one of inducing sleep andmaintaining sleep.
 11. The method of claim 8, wherein the composition isadministered to a user once daily prior to the user going to sleep. 12.The method of claim 8, wherein the composition comprises a time-releasemechanism providing about 4 hours of active compound release.
 13. Themethod of claim 8, wherein composition is provided in the form of acoated tablet, and the melatonin is incorporated into the tabletcoating.
 14. The method of claim 8, wherein at least a portion of themelatonin is fine-milled.